Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR202102867544936 Date of Approval: 22/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Endothelial Dysfunction during The COVID-19 follow-up: TUN-EndCOV study
Official scientific title Endothelial Dysfunction during The COVID-19 follow-up: TUN-EndCOV study
Brief summary describing the background and objectives of the trial The endothelial dysfunction during the COVID-19 acute phase may hold to vascular homeostasis dysregulation therefore organ perfusion impairment . Data about the persistence of the endothelial dysfunction during the COVID-19 infection follow-up are missing. The purpose of the study is to evaluate the presence of endothelial dysfunction with a non-invasive evaluation of systemic endothelium-dependent microvascular reactivity - using DTM - at the post COVID-19 infection. Diagnostic Tests : Evaluation of the microvascular flow and reactivity The microvascular flow and reactivity was evaluated with “E4-Diagnose” Polymath Tunisia (7). The DTM assessments were operator independent. The DTM thermal probes were attached to the index finger, and thermal changes because of cuff occlusion were automatically recorded using Polymath software. The microvascular flow and reactivity were evaluated in eligible patients after 6 hours fasting and at rest (It was recommended to don’t practice any intensive physical activities in the last 24 hours).
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 07/02/2021
Actual trial start date
Anticipated date of last follow up 07/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group treatment 21 days Patients with endothelial dysfunction defined by an endothelium quality index (EQi) ≤ 1.5 will be able to receive medical treatment such sulodexide, nebivolol, colchicine or other molecules at the discretion of the investigator 500
Control Group no intervention 21 follow up 100 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• age >18 years, both sexes; • written informed consent; • a recent diagnosis of COVID19 (1 - 6 months) proven by RT-PCR or viral rapid test. • Age <18 years • Inability to express consent of the study • Diseases carrying out a life -expectancy <1 year according to clinical judgment • Pregnancy and breastfeeding • Foreseen inability to attend scheduled visits 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/01/2021 CPP Sud
Ethics Committee Address
Street address City Postal code Country
elain street, km 5, internal medecine department sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The evaluation of microvascular reactivity in post COVID-19 patients with DTM at 21-days follow-up. 21 days
Secondary Outcome The CV events – mortality 1, 3 and 12 months after patient’s inclusion. The predefined secondary outcome was a new cardiovascular event. Patients were followed for the development of cardiovascular disease, defined as death, an acute coronary syndrome, a cerebrovascular event, pulmonary embolism or deep venous thrombosis or hospitalizations due to cardiac events. one, 3 ans and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
hedi chaker hospital elain street sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Pr Leila Abid is the Principal investigator elain street sfax 3029 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor no sponsor no sponsor no sponsor Tunisia University
COLLABORATORS
Name Street address City Postal code Country
abdessalem salel urbain nord tunis Tunisia
rania hammami elain street sfax 3029 Tunisia
selma charfeddine elain street sfax 3029 Tunisia
bahloul amine elain street sfax 3029 Tunisia
hadjamor hassen mahdia mahdia Tunisia
touil Imen mahdia mahdia Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator leila abid leilaabidt@yahoo.fr +21698230250 elain street
City Postal code Country Position/Affiliation
sfax 3029 Tunisia cardiology departement hedi chaker hospital
Role Name Email Phone Street address
Public Enquiries leila abid leilaabidt@yahoo.fr +21698230250 elain street
City Postal code Country Position/Affiliation
sfax Tunisia Cardiology departement hedi chaker hospital sfax
Role Name Email Phone Street address
Scientific Enquiries leila abid leilaabidt@yahoo.fr +21698230250 elain street
City Postal code Country Position/Affiliation
sfax Tunisia cardiology departement hedi chaker hospital sfax
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol Immediately following publication investigators
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 10/02/2021 age category added Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/02/2021 we forgot to upload the file TRUE, CPP Sud, elain street, sfax, 3029, Tunisia, , 27 Jan 2021, 98656704, zouhir.bahloul@rns.tn, 14657_12999_4737.pdf TRUE, CPP Sud, elain street, km 5, internal medecine department, sfax, 3029, Tunisia, , 27 Jan 2021, 98656704, zouhir.bahloul@rns.tn, 14657_12999_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 20/02/2021 self funding Pr Leila Abid is the Principal investigator, elain street, sfax, 3029, Tunisia, Self Funded,